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zuranolone

Zurzuvae · ATC code N06A

Also known as: Zuranolon

Key facts
Active substance
zuranolone
Drug class
Antidepressant
ATC code
N06A
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Zurzuvae 20 mg hard capsules / Zurzuvae 25 mg hard capsules / Zurzuvae 30 mg hard capsules
Marketing authorisation holder
Biogen Netherlands B.V.
Information as of
2026-10-27

Key facts

Zuranolone is an oral neuroactive steroid used to treat postpartum depression in adults following childbirth.

What it is used for

  • Postpartum depression in adults following childbirth

Dosing

  • 50 mg (two 25 mg capsules) once daily in the evening for 14 days as a single course
  • If not tolerated, reduced to 40 mg once daily; may be stopped without down-titration
  • Taken with fat-containing food; a missed dose is not made up on the same day
  • With strong CYP3A inhibitors: 30 mg once daily
  • Moderate or severe renal impairment and severe hepatic impairment: 30 mg once daily
  • Alone or with stable background oral antidepressant therapy

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Pregnancy

Important warnings

  • Impaired driving ability: no driving or hazardous activities until at least 12 hours after each dose
  • CNS depressant effects such as somnolence and sedation; dose reduction or discontinuation as needed
  • CYP3A inducers should be avoided
  • Potential for abuse and dependence

Side effects

  • Very common: somnolence, dizziness, sedation
  • Common: memory impairment, confusional state, tremor, diarrhoea, fatigue
  • Serious adverse reaction: confusional state

Interactions

  • Alcohol and other CNS depressants (opioids, benzodiazepines, gabapentinoids, sedating antidepressants) increase impairment; dose reduction considered
  • CYP3A inducers such as rifampin markedly reduce exposure and may reduce efficacy

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; effective contraception during treatment and for 7 days after
  • Present at low levels in breast milk; breast-feeding generally discontinued during treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ZurzuvaeBiogen Netherlands B.V. · EMEA/H/C/006488

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Zurzuvae
Liechtenstein
Zurzuvae
Norway
Zurzuvae

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Zurzuvae – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/zurzuvae-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N06A.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.